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RecruitingNCT06771531BSFSUpdated Sep 23, 2026

Brain Stimulation for Foot-sole Sensation in Older Adults With Foot-sole Somatosensory Deficits

An interventional study of transcranial direct current stimulation and active sham stimulation in Somatosensory Function, Balance Control and Mobility, sponsored by Hebrew SeniorLife. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Hebrew SeniorLife · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
65 Years and older
Sex
All
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Study summary

In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.

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Conditions studied

  • Somatosensory Function
  • Balance Control
  • Mobility

Keywords

  • brain stimulation
  • balance and mobility
  • foot-sole somatosensory function
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In context

Lead sponsor

Hebrew SeniorLife is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged ≥65 years.
  2. Self-reported feeling of unsteadiness or difficulty when standing and walking.
  3. Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.

Exclusion criteria

Exclusion Criteria:

  1. self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed);
  2. history or presence of foot ulceration, amputation, or deformities;
  3. self-reported uncontrolled pain or pain that is associated with mobility disability;
  4. uncontrolled diabetes mellitus;
  5. hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance;
  6. persistent severe pain of lower extremity when standing or walking;
  7. diagnosis of dementia, Parkinson's disease, or stroke that affects balance;
  8. unstable medical condition;
  9. legal blindness or deafness;
  10. uncontrolled hypertension (i.e., systolic BP >180, diastolic BP >100 mm Hg, or prescription of ≥3 anti-hypertensive medications);
  11. functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure;
  12. active cancer treatment;
  13. balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome;
  14. use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability;
  15. contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery);
  16. persistent vertigo;
  17. history of Charcot-Marie-Tooth nerve disease.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    tDCS group

    Participants in this arm will receive the real tDCS intervention.

    Device: transcranial direct current stimulation

  • Sham comparator
    sham group

    Participants in this arm will receive the sham stimulation as control.

    Device: active sham stimulation

Interventions

  • Devicetranscranial direct current stimulation

    tDCS can safely and selectively modulate cortical excitability (specifically neuronal firing likelihood) by transferring weak electrical currents between scalp electrodes. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA in this study.

  • Deviceactive sham stimulation

    sham stimulation will implement the same protocol of the tDCS intervention; however, only very low-level currents (no more than 0.5 mA) are transferred between the same electrodes used for the tDCS throughout the 20-minute session. This strategy effectively mimics the cutaneous sensations and skin redness induced by creating only micro cortical electric fields.

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What researchers measure

Primary outcomes

  1. postural sway area when standing with eyes closed on the foam

    This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.

    Time frame: Before and immediately after intervention

  2. Timed Up-and-Go (TUG) time

    This metric assesses mobility.

    Time frame: Before and immediately after intervention

  3. On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation

    This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation.

    Time frame: Before and immediately after intervention

  4. Standing vibratory thresholds of each foot sole

    This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.

    Time frame: Before and immediately after intervention

Secondary outcomes

  1. Postural sway speed when standing with eyes closed on the foam

    This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.

    Time frame: Before and immediately after intervention

  2. Gait speed of 10m walking test

    This metric assesses mobility.

    Time frame: Before and immediately after intervention

Other outcomes

  1. BOLD signal intensity within other relevant cortical regions in response to foot sole stimulation

    This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation.

    Time frame: Before and immediately after intervention

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Study locations

1 of 1 sites recruiting
  • Hebrew SeniorLife
    Roslindale, Massachusetts 02131, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06771531
Lead sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA)
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Feb 26, 2026
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 23, 2026

Study contacts

Junhong Zhou, PhD
Contact
junhongzhou@hsl.harvard.edu
617-971-5346

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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